Guidant Ancure Endograft

Guidant Corp. pleaded guilty to failing to file thousands of medical device reports with the FDA regarding malfunctions of its Ancure Endograft System, including malfunctions that may have led to 12 deaths, 56 emergency operations, and many other complications.

The Ancure device is used to treat an abdominal aortic aneurysm, a weak spot in the wall of the large artery that carries blood from the heart to branch arteries throughout the body. The device consists of a delivery system and an implant. In a minimally invasive operation, a surgeon makes a small incision in the patient's groin, inserts a tube (catheter) through the artery, and implants a graft into the aorta in the abdomen. The graft stays in the body permanently, but the delivery catheter is removed.

Under federal law, companies are required to submit to the FDA a medical device report of any incident in which its device caused, or may potentially cause, harm to a patient. By failing to file the required reports, Guidant put patients at risk of serious injury and death.

If you or a loved one suffered injuries from a Guidant Ancure graft, please contact a lawyer at PritzkerOlsen, P.A. for a free consultation. You may call toll-free at 1-888-377-8900 or submit the firm’s online consultation form for review by an attorney.

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